Analytical Testing
Analytical testing of purified mRNA is critical for understanding the final drug product. Multiple analytical tests such as potency assays, enzymatic digestions to study 5’ cap and 3’ PolyA tail, and transcript size and purity studies are performed. Speed of analysis and sample prep is important as mRNA can degrade quickly. Prepare samples in microplates with a Beckman Coulter Life Sciences Biomek i-Series Automated Liquid Handler, or quickly array large amounts of samples with a Beckman Coulter Life Sciences Echo Acoustic Liquid Handler and analyze for concentration and purity on a Molecular Devices SpectraMax plate reader. A SCIEX Exion 2.0 Liquid Chromatographer, ZenoTOF 7600 mass spectrometerand Phenomenex BioZen Oligo analytical HPLC columns provide a comprehensive analytical solution for LC-MS. Perform capillary electrophoresis analyses with eight samples in parallel with SCIEX Biophase 8800 Multi-Capillary Electrophoresis System. It is important to validate all analytical assays and select the proper tools that can scale to your needs.
With the Genedata Biopharma Platform, capture, analyze and manage all analytical testing of mRNAs or final product, including for validated environments. Covering chromatography, capillary electrophoresis, mass spectrometry, qPCR, absorbance assays and more, the software automates and harmonizes analysis. By capturing and annotating all data and metadata in a systematic way, the Genedata Biopharma Platform provides a robust and high-quality data foundation for predictive modeling and AI/ML.